Study to Determine the Feasibility of Sentinel Node Biopsy in Patients With Anal Cancer

NCT02162641 | Withdrawn DMC

• 2 other identifiers: 13_DOG03_261CFTSp081
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is assess the technical and operational feasibility of a specialised biopsy technique, sentinel lymph node biopsy (SLNB), in patients with anal cancer.

Conditions

Squamous Cell Carcinoma of the Anus

Outcome Measures

Primary Outcomes (1)

• The proportion of nodes detected will be expressed per inguinal nodal basin and per number of patients

  Day 0 (Day of SLNB)

Secondary Outcomes (3)

• Micro-metastatic disease within sentinel nodes

  Days 7 to 10

• Surgical complications

  Up to 15 weeks after SLNB

• Delays in receiving radiotherapy treatment

  15 weeks after SLNB

Study Arms (1)

SCC of the anus

Procedure: Sentinel lymph node biopsy

Interventions

Sentinel lymph node biopsy PROCEDURE

SCC of the anus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with squamous cell carcinoma (SCC) of the anus with clinically negative or equivocal nodal involvement; and for consideration of chemo-radiotherapy, local excision or salvage surgery treatment. The majority will be initial presentations, but patients with recurrent disease may also be considered.

You may qualify if:

• Patients with squamous cell carcinoma (SCC) of the anus (any T size and/or those with recurrent disease)
• Equivocal lymph node involvement on standard CT staging or magnetic resonance (MR) staging or PET-CT scan, as determined by the anal cancer multidisciplinary team (MDT)
• Age \>= 18 years
• Written informed consent provided by the patient

You may not qualify if:

• Patients with unequivocal lymph node involvement on standard CT staging or MR staging, as determined by the anal cancer MDT.
• Unfit for surgical biopsy
• Patients undergoing palliative treatment
• Previous pelvic or inguinal area radiotherapy
• Other coincident cancers
• Previous inguinal surgery (e.g. hernia repair) with mesh insertion

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

MeSH Terms

Conditions

Anus Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Andrew G Renehan

  The Christie NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Trials Project Manager

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 13, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 3, 2015

Record last verified: 2015-06